PreDiabetesNCT06542627
Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes: A Prospective Community-based (Workplace) Cohort Study
A study testing Freestyle Libre in people with PreDiabetes and Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital at 1 site in South Korea.
Trial summary
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- PreDiabetes, Diabetes Mellitus, Type 2
- What is being tested?
- Freestyle Libre
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 420 participants
- Where
- 1 siteSouth Korea
- Study dates
- 22 May 2023to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects over the age of 19
- Patients with type 2 diabetes
- Fasting blood glucose ≥ 126 mg/dL or
- HbA1c ≥ 6.5% or
- Type 2 diabetes by clinical history and treated with antidiabetic medications or lifestyle Modifications
- Patients with prediabetes
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- Fasting blood glucose 100-125 mg/dL
- HbA1c 5.7-6.4%
- Willing to participate in the study
Who cannot join
- Subjects less than 19 years old
- Patients with type 1 diabetes
- Pregnant at the time of screening or planning to become pregnant during the study
- Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
- Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
- Severe liver disease (e.g., cancer, liver cirrhosis, hepatitis B, hepatitis C)
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- Diseases of the biliary tract, thyroid disorders, autoimmune disorders, or acute infections
- Planning to be admitted to a hospital within 2 months
- Unable to participate in the mobile intervention study as determined by the investigator
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Kangbuk Samsung Hospital
Seoul, 03181
Cheol-Young Park, MD, PhD, +82220011550, cydoctor68@gmail.com
Jihee Ko, MD, +82220011550, sjaks999@gmail.com
About this study
Official title: Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Being tested
- Freestyle Libre
- Medical subject headings
- Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle LibreDevice
Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education.
| Study group | Role | What they receive |
|---|---|---|
| CGM arm | Experimental | Glycemic control was monitored using CGM data for two weeks, followed by individualized dietary education. Receives: Device: Freestyle Libre |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
HbA1c assessed by blood test after 2-week use of CGM and dietary education
Measured: 8weeks after intervention
Secondary outcomes (5)
Fasting blood glucose
Fasting blood glucose, assessed by blood test after 2-week use of CGM and dietary education
Measured: 8weeks after intervention
Lipid profiles
Lipid profiles (total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride), assessed by blood test after 2-week use of CGM and dietary education
Measured: 8weeks after intervention
Body weight
Body weight assessed by blood test after 2-week use of CGM and dietary education
Measured: 8weeks after intervention
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of three parts.
- total satisfaction (minimum 0, maximum 36, higher scores mean a better outcome.)
- perceived hyperglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)
- perceived hypoglycaemia (minimum 0, maximum 6, higher scores mean a worse outcome.)
Measured: 8weeks after intervention
Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).
Pre- and post-intervention questionnaires, assessed by self-reported survey. The questionnaire is composed of five parts.
- diet (values: minimum 0, maximum 28, higher scores mean a better outcome.)
- exercise (minimum 0, maximum 14, higher scores mean a better outcome.)
- blood sugar check-up (values: minimum 0, maximum 14, higher scores mean a better outcome.)
- foot care (minimum 0, maximum 14, higher scores mean a better outcome.)
- smoking (minimum 0, maximum 1, higher scores mean a worse outcome.)
Measured: 8weeks after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start22 May 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreDiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 420 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangbuk Samsung Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Principal investigator, Cheol-Young Park, Kangbuk Samsung Hospital
- Investigators
- Park, Study director, cydoctor68@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542627
- Sponsor's protocol ID
- KBSMC 2023-05-010
- Status last verified
- Aug 2024
- First submitted
- 1 Aug 2024
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Continuous Glucose Monitoring for Glucose and Weight Management in Prediabetes and Non-severe Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT06542627
- Acronym / sponsor ID
- KBSMC 2023-05-010
- Conditions
- PreDiabetes, Diabetes Mellitus, Type 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 420 participants (estimated)
- Lead sponsor
- Kangbuk Samsung HospitalUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 22 May 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to evaluate the effectiveness of use of Continuous Glucose Monitoring (CGM), combined with personalized dietary education and use of smartphone applications in improving glucose control and weight management.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CGM arm | Experimental | Device: Freestyle LibreGlycemic control was monitored using CGM data for two weeks, followed by individualized dietary education. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects over the age of 19
- Patients with type 2 diabetes
- Patients with prediabetes
- Willing to participate in the study
Key exclusion criteria (9 listed)
- Subjects less than 19 years old
- Patients with type 1 diabetes
- Pregnant at the time of screening or planning to become pregnant during the study
- Severe chronic diseases such as cancer, stroke, proliferative retinopathy, myocardial infarction, chronic renal disease, or amputation of a diabetic foot
- Diagnosed with or treated for myocardial infarction, stroke, end-stage renal disease, liver failure, or chronic lung disease within the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Freestyle LibreGlycemic control was monitored using CGM data for two weeks, followed by individualized dietary education. | Device | CGM arm |
Primary outcome
HbA1c
Time frame: 8weeks after intervention
HbA1c assessed by blood test after 2-week use of CGM and dietary education
5 secondary outcomes
Fasting blood glucose
Time frame: 8weeks after intervention
Lipid profiles
Time frame: 8weeks after intervention
Body weight
Time frame: 8weeks after intervention
Pre- and post-intervention questionnaire: Diabetes Treatment Satisfaction Questionnaire (DTSQ)
Time frame: 8weeks after intervention
Pre- and post-intervention questionnaire: Summary of Diabetes Self-Care Activities Questionnaire (SDSCAS).
Time frame: 8weeks after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Park study director
cydoctor68@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Freestyle Libre in people with PreDiabetes and Diabetes Mellitus, Type 2, run by Kangbuk Samsung Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Park (0220011550, cydoctor68@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 8weeks after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2024.